Erasca

Biotech

ClinicalTrialManager/SrClinicalTrialManager

$7500–12000k ~AI est. Remote Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“Clinical Trial Manager/Sr Clinical Trial Manager at Erasca. Skills: Clinical trial management, Oncology indications, Vendor management. Manage global clinical trials. Recruit global study sites”

Industry & Context.

Biotech

What They're Looking For.

Must Have

5 years of relevant experience, 7 years of relevant experience, ICH-GCP guidelines experience, US and ex-US regulations experience, Electronic data capture experience, Data management software experience, Clinical Research Associates management experience, Reviewing monitoring trip reports experience

Nice to Have

Undergraduate degree in life sciences

What You'll Do.

Manage global clinical trials

Recruit global study sites

Foster relationships with study investigators

Participate in site selection

Participate in vendor selection

Participate in site qualification

Participate in vendor qualification

Participate in site activation

Develop Requests-for-Proposals

Assist in vendor selection efforts

Assist in review vendor contracts

Assist in negotiation vendor contracts

Assist in review study site agreements

Assist in negotiation study site agreements

Monitor trial progress

Track trial enrollment

Track clinical trial material inventory

Review monitoring visit reports

Assist in packaging clinical trial material

Assist in labeling clinical trial material

Assist in distribution clinical trial material

Monitor biological samples

Track biological samples

Provide progress updates to management

Provide progress updates during meetings

Assist in departmental budgeting

Assist in projections

Assist in development protocols

Assist in development consent forms

Assist in development IRB/EC materials

Assist in development trial documents

Assist in development Clinical SOPs

Prepare study materials

Review study materials

Approve study materials

Assist in electronic case report form design

Assist in electronic case report form development

Assist in IRT development

Participate in data cleaning

Develop appropriate data outputs

Fulfill needs of other Erasca departments

Provide leadership to team members

Perform duties in keeping with core values

Perform duties in keeping with policies

Perform duties in keeping with regulations

How You'll Work.

Team & Collaboration

Global multi-disciplinary teams; Program team meetings; Other Erasca departments

Communication Scope

Oral communication; Written communication

Process & Methodology

Clinical trial management, Project management, Priority management

Full Job Description

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “Erasca” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer. The Clinical Trial Manager or Senior Clinical Trial Manager assists in the planning, implementation, and management of clinical studies from concept to completion. The position requires knowledge of clinical trial processes and prior experience in many aspects of trial execution from study start-up to study close-out, including assisting in the management of clinical vendors/CROs and assisting in the oversight of resources, budgets, contracts, and timelines. Essential Duties and Responsibilities: Manage global clinical trials (Phase 1-3) in oncology indications, ensuring that studies are carried out in accordance with the clinical development plan, ICH-GCP, and FDA/other regulatory agency requirements. Recruit global study sites and foster relationships with study investigators. Participate in the process of site and vendor selection, qualification, and activation. Develop Requests-for-Proposals and assist in vendor selection efforts. Assist in review and negotiation of vendor contracts and study site clinical trial agreements. Manage study vendors (e.g., CRO, IRT, laboratories, core ECG/imaging). Monitor the progress of trials, including enrollment and clinical trial material inventory. Review monitoring visit reports for completeness and adherence to the annotations. Assist in packaging/labeling/distribution of clinical trial material. Monitor and track biological samples for applicable analyses. Provide progress upda

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